In brief perspective, after 2,000 years using the most advanced technology available anywhere in the world, the actual processes and causes of Celiac, gluten sensitivities, and many other life threatening and taking diseases with origins in the gut, such as those resulting from gluten or other protein effects, remain unknown today. Likewise, there no known medications or procedures that can cure said diseases, and hundreds, if not thousands, of medications are applied to treat only their symptoms. The fecal-oral cycle of pathogens entering the digestive tract has also greatly increased in the U.S. Now, microbial diseases of the gut rank second in humans only to the respiratory system. While in vivo sampling of the respiratory and cardiovascular fluids is routinely performed with minimal cost, patient inconvenience, and time consumption, sampling of the gastrointestinal tract is extremely technology limited. It is estimated that of the more than 10,000 strains of bacteria in the GI tract, and perhaps exceeding more than a trillion in total number, less than 5% have even been identified, much less characterized. This is understandable since critical regions of the gut are inaccessible for in vivo sampling, observation, monitoring, or direct treatment. As in virtually all current in vivo sampling of masses of the human body, analyses are performed in vitro. However, procedures for testing of gut matter, especially below the stomach and lower colon, are routinely in vitro collected samples of feces expelled from the anus after experiencing all of the conditions and biological processes throughout the small and large intestines, and then are in vitro analyzed. At this point any trace of the causative processes from within the areas of origin, such as the small intestine jejunum, are totally camouflaged, modified, or destroyed. In addition, collection of expelled feces itself exposes the samples to aerobic conditions and other potential contamination. Since at this stage the collected stool may be 50% or more microbes of many thousands of species, strains, and other taxonomic levels, tests are not only difficult, but unrevealing and inconclusive. Microbe isolations and species association with any gut phenomena must be performed by in vivo sampling at points of interest in the natural gut environment, and preserving those samples at least for in vivo analysis, and at best, identified and characterized to the extent possible in vivo in the natural or perturbed environment.
Although the principal interest here is human health, the importance of GI tract processes and microbes in all animals needs more emphasis and greater analysis and diagnostic technologies as part of human health considerations. As the world population of all animals increases and food supplies and all aspects of our world population becomes more dense and integrated as a single community, the oral-feces cycles become more important. Waste products from all animals are becoming of greater importance, and microbes of the gut as herein addressed desperately need more attention, and more technology to aid in understanding their roles. Food digestion processes need to be investigated by multidisciplinary physicians and medical personnel and scientists and engineers of many other disciplines to really analyze the many gut processes in totality, including the roles of some 10,000 species of microbes, along with other patient unique data. Specific patient-food incompatibilities fall into many categories, and this Invention III, Capsule C provides for the small increment sampling, testing, patient-specific testing and system perturbation capability to evaluate and resolve such issues. Another area of importance is the impacts antibiotics and other ingested chemicals have within the gut environment at the point of application. The technology introduced by this Capsule C capability not only allows point, condition, and time specific delivery, but likewise, on the spot monitoring and partial analyses of results.
The stakes are high and the impacts of all these human health related issues reach all levels and aspects of our civilization. The second highest frequency of human diseases are associated with the gut, and over a period of time, the highest number of serious diseases are believed to originate in the gut directly, or indirectly as a result of conditions within the gut. This should place extremely high national and international priority upon developing the capability of efficient, cost-effective, and technically-effective gut sampling and diagnostic capabilities, and certainly with all aspects of patient considerations highly ranked in seeking solutions. This inventor actually suffers from some variation of gluten sensitivities, which actually led to this research and technology development project. There is also an even greater motivation. Undiagnosed gluten sensitivity conditions also caused misery for several years, and ultimately led to the cause of death of both of his parents. Therefore, the research leading up to this invention and its development is heavily engendered with passion and urgent concern for patients. However, as a career research engineer fortunately versed in several disciplines including biomechanics, this technology is also being developed with an unusual history of understanding, and an intrinsic level of experience with the processes and related issues, as well as, the types of new technologies needed. He has conducted extensive experiments with diet on his own body and documented the results, and formed many hypotheses pertaining to the fundamental causes of said illnesses and diseases. This invention is therefore, based upon addressing this national and world-wide need for improving human health in a realistic, meaningful, methodical, urgent, technology-based, and results-oriented manner.
The first invention by Shuck (U.S. patent Ser. No. 13/691,169) of which this is a continuation, was a serious accomplishment toward this overall objective, and the second invention entitled, “In Vivo Device for Researching GI Tract Processes, Microbes, and Variables Associated with Digestion, Illnesses and Diseases” and referenced as Invention II Capsule B, was a second step toward researching the phenomena to reach some level of understanding of the actual causes of the illnesses, and providing researchers of all disciplines with a tool and the missing technology that would give them the best opportunity to be successful in such efforts within their areas of specialization. Further background, methodologies, and implication details of this multi-stage technology development project are explained in the above referenced documents.